FDA 510(k) Application Details - K052030

Device Classification Name Surgeon'S Gloves

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510(K) Number K052030
Device Name Surgeon'S Gloves
Applicant SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
9 MOO 4 KACHED MUANG
RAYONG 21110 TH
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Contact ANAN JETSADAWISUT
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 07/27/2005
Decision Date 09/13/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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